摘要
目的为药品生产企业实施新版GMP提供帮助。方法对《药品生产质量管理规范》(2010年修订)新增内容:偏差处理、纠错及预防措施、变更控制进行了探讨,阐述其定义、分类及具体操作程序。结果与结论药品生产企业不必害怕发现偏差,应正确对待偏差,认真按照偏差调查、纠错及预防措施和变更控制的操作程序实施并做好相关记录。这不仅有利于改进产品质量,提高质量标准,在日益激烈的商业竞争中拥有自己的技术壁垒和知识产权,提高其市场竞争力;而且在GMP认证中,可以提高GMP检查专员对企业的认同感,有利于企业顺利通过GMP认证。
Objective To give a help to Pharmaceutical manufacturers in their application of a new edition of GMP. Methods The deviation handling, Corrective Action and Preventive Action （CAPA） and Changes Control added in the ＂Drug Manufacture Quality Manage Standard＂ （Revised in 2011） were discussed and their definitions, classifications and specific operating procedures were also explained. Results and Conclusion Pharmaceutical manufacturer should not worried about discovering deviation but treat deviation properly and implement seriously according to deviation examination, CAPA and changes control operating procedures, and document related notes. It will not only improve product quality, raise quality standard, have own technological barrier and intellectual property in a increasingly intense commercial competition environment, increase market competition capability, but also enhance the acceptance of GMP inspector to enterprise during the GMP certification to facilitate the pass of the GMP certification.
出处
《中国药事》
CAS
2012年第6期646-649,共4页
Chinese Pharmaceutical Affairs
关键词
生产质量控制
偏差处理
纠错及预防措施
变更控制
manufacturer quality control
deviation handing
Corrective Action and Preventive Action （CAPA）
change control
